Cleared Traditional

K091688 - A-GRIX RESORBABLE BONE VOID FILLER

K091688 is an FDA 510(k) clearance for A-GRIX RESORBABLE BONE VOID FILLER, manufactured by Ag Digital Technology Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K091688 · Ag Digital Technology Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
265d
Days
Class 2
Risk

K091688 is an FDA 510(k) clearance for the A-GRIX RESORBABLE BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ag Digital Technology Corp. (Flagstaff, US). The FDA issued a Cleared decision on March 2, 2010 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ag Digital Technology Corp. devices

FDA 510(k) Submission Details - K091688

510(k) Number K091688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date March 02, 2010
Days to Decision 265 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 307
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K091688.
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
K101557 · Etex Corp. · Jul 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · Collagen Matrix, Inc. · May 2010
NANOSS BONE VOID FILLER
K100361 · Pioneer Surgical Technology · Apr 2010
CARRIGEN
K093447 · Etex Corp. · Feb 2010
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302 · Integra LifeSciences Corporation · Dec 2009
PIONEER SURGICAL NANOSS BVF-E
K091031 · Pioneer Surgical Technology · Nov 2009